Feature Articles
Top 10 Molecular Diagnostics Companies
The following 10 names are the molecular-diagnostics industry’s heaviest hitters. Listed in descending order, these 10 firms brought in the greatest molecular-related revenues in 2012. (Update May 15, 2013: An error regarding Digene's ownership has been corrected.) If you follow this industry, there won’t be any enormous surprises here. Bruce Carlson, Publisher, Kalorama Information, points out that these are the 10 companies “that have almost always showed up” on the...
A Risk-Management Roadmap for Clinical Laboratories
Clinicians often place a great deal of blind faith in the results of IVD medical devices. Staff assumes if a device gives a result, then that result must be correct. Glucose meters, pregnancy tests, blood gas analyzers and coagulation devices are all considered equivalent to central laboratory instrumentation, only faster. Yet, central laboratory testing is conducted under well monitored and controlled conditions, while these point-of-care testing (POCT) devices are subjected to a variety of...
In Case You Missed It: Infographic Highlights the Value of IVDs
Did you know: Diagnostics R&D spending is 10 times the average among U.S. industries? Diagnostics can decrease healthcare-associated staph infection rates by 70%? 4000 IVD tests are currently available for clinical use? These impressive IVD-industry facts and others are presented on the AdvaMedDx infographic "Diagnostics Transforming Care," which originally appeared (and is still available) on the AdvaMedDx website and has been posted here with permission of AdvaMedDx. If you...
At HiberGene, Molecular Diagnostics Tackles Meningitis
  HiberGene Diagnostics CEO Tony Hill As part of our new monthly series on emerging IVD companies, IVD Technology spoke with Tony Hill, CEO of HiberGene Diagnostics Ltd., a young company based in Dublin, Ireland. Hill's company has developed a rapid and highly sensitive molecular diagnostic test for bacterial meningitis, which the company hopes to introduce to the European market in Quarter 4 of this year, with a U.S. introduction a year later.   Please give us...
The IVD Miniaturization Paradigm
  An integrated MEMS-microfluidics sensor device (actual size). Green printed circuit board layers support a silicon chip and acrylic microfluidic interface. A four-tube (850-micrometer Tygon) interface is attached to the right side. IVD technology is following a path trod by many other industries: as product sizes decrease, the level of integration increases. Integration allows the same machine or person to handle a smaller yet higher-level system using the same or smaller...
Innovations in Anatomic Pathology Lab Automation
The anatomic pathology lab is rapidly evolving and, if current trends continue, fully automated digital pathology will soon become the norm. Not every lab scans every processed specimen slide to create digital images—not yet, at least. But compare the speed and convenience of transmitting digital files via the Internet or intranet with physically transporting glass slides, and the transition to digital pathology seems inevitable. The biggest innovations in medical diagnostic systems are...
Three Strategies for Assessing IVD Instrument Feasibility Early in the Design Process
Rapid product development reaps well-known rewards: accelerated time to market and lower development cost. Successful Figure 1: Example of a common IVD instrument architecture using a heated wheel of cuvettes with a reagent dispenser at a fixed position. The incubation wheel can hold up to 15 cuvettes. Each cuvette passes out of the incubation wheel block when its duration time has expired. The sample generator creates items (cuvettes) that flow through the model. Cuvettes are...
Point-of-Care Molecular Diagnostic Testing
Appropriate early treatment of hospital-acquired infections (HAI) has been associated with lower treatment costs and improved patient outcomes. Current culture-based methods for diagnosing HAI are either slow or poorly sensitive/specific; therefore, broad-spectrum antimicrobial therapy is often initiated when there is clinical suspicion of infection. This approach may not be effective when dealing with inherently resistant organisms and can result in iatrogenic infections. Amplification and...
A Modular Approach to Customizing IVD Instruments
Recently developed rapid tests provide significant improvements that increase the scope and reliability of these tests. The trend toward rapid tests that enable quantitative interpretation through an objective measurement creates market demand for Figure 1. After an assay-specific method is completed, the accompanying file is downloaded to the reader. the development of corresponding reader systems and accompanying software. At the same time, rapid test manufacturers usually have...
Ten Economic Motivators for Patient-Centric Diagnostics
When Jennifer went to her endocrinologist after almost three years of living with a mysterious nexus of symptoms and a large differential diagnosis, her doctor put an iPad in her hands. For years, she was accustomed to going months between tests and receiving single, typewritten, numeric results. This system was replaced by high-frequency diagnostics combined with data that she was acquiring and managing herself. Since her last visit, Jennifer had been mailing dried capillary blood spots to a...